Identity
- Trade Name
- Alpha-Tec Systems FDA UDI
- Generic Name
- Biological stain control IVD FDA UDI
- Device Name
- AFB Stain Control Slides FDA UDI
- Model / Reference
- 0 FDA UDI
- Description
- AFB Stain Control Slides FDA UDI
Identifiers
- Catalog Number
- 0003245 FDA UDI
- Primary DI / UDI-DI
- 00816085020525 FDA UDI
- 510(k) Number
- K823706 FDA UDI
- FDA Product Code
- LJG FDA UDI
- GMDN Term
- Biological stain control IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Biological stain control IVD
Alpha-Tec Systems by Alpha-Tec Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K823706 also covers:
- Alpha-Tec Systems — Alpha-Tec Systems, Inc.
- Alpha-Tec Systems — Alpha-Tec Systems, Inc.
- Alpha-Tec Systems — Alpha-Tec Systems, Inc.
- Alpha-Tec Systems — Alpha-Tec Systems, Inc.
- Alpha-Tec Systems — Alpha-Tec Systems, Inc.
- Alpha-Tec Systems — Alpha-Tec Systems, Inc.
- Alpha-Tec Systems — Alpha-Tec Systems, Inc.
- Alpha-Tec Systems — Alpha-Tec Systems, Inc.
- Alpha-Tec Systems — Alpha-Tec Systems, Inc.
- Alpha-Tec Systems — Alpha-Tec Systems, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Alpha-Tec Systems, Inc.
Sources (1)
- FDA UDI cd6af857-5567-4aa4-82c6-4418a1db9c95 35 fields · synced Jun 1, 2026